Director, Systems Engineering

Heartflow • San Francisco, CA

1d • $220,000 - $290,000 • Hybrid

About The Position

As the Director of Systems Engineering, you will lead the R&D efforts for system-level design and architecture within our medical device software SDLC. You will be responsible for bridging the gap between unmet clinical needs and engineering execution, ensuring our SaMD products remain compliant, innovative, and patient-centric.

Requirements

• Extensive Leadership: 10+ years of experience leading cross-functional teams spanning systems, test, and human factors engineering in regulated medical device environments.
• Proven Scaling Record: Demonstrated success in growing engineering organizations (e.g., scaling teams from 1 to 10+ engineers).
• Architecture Expertise: Proven track record of owning end-to-end architecture for complex diagnostic platforms, contributing to successful regulatory clearances.
• Analytical Power: High proficiency in using data analytics tools to drive root cause analysis and product improvement.
• Technical Foundation: Strong background in software integration and delivery.
• Educational Excellence: B.S. in Engineering or equivalent degree

Responsibilities

• Systems Architecture & Design: Lead the end-to-end architecture for HeartFlow’s clinical software platform, focusing on new algorithms, reducing turnaround time and expanding clinical insights
• Human Factors Engineering (HFE): Manage the HFE function to ensure user-centric design is integrated into the SDLC, focusing on safety, usability, and clinical efficacy for medical professionals.
• Team Leadership: Scale and mentor a cross-functional engineering organization, reinforcing standardized design and review processes.
• Software SDLC & Compliance: Oversee the systems engineering deliverables within a regulated environment, ensuring successful 510(k) clearances and adherence to design controls.
• Data-Driven Insights: Leverage SQL and Python to synthesize field data and clinical performance metrics to establish root cause and drive data-backed corrective actions.
• Performance Optimization: Partner with algorithm and software teams to define and track key performance metrics, ensuring high accuracy and reliability across all user needs.
• Continuous Improvement: Modernize design infrastructure and workflows to improve traceability, quality, and cross-functional alignment across the R&D organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Director